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Completed

NCT Number: NCT02952599

Edoxaban Treatment in Routine Clinical Practice in Patients With Venous Thromboembolism in Korea and Taiwan (ETNA-VTE-KOR-TWN)

According to current guidelines, duration of anticoagulant treatment after a venous thromboembolic event varies from 3 months to indefinite treatment depending on the estimated risks of venous thromboembolism (VTE) recurrence and bleeding. Current data for edoxaban are limited to a maximum treatment duration of 12 months.

Therefore, this study aims to gather further insight into efficacy (i.e. symptomatic recurrent VTE) and safety (i.e. bleeding events, liver adverse events, all-cause mortality and other drug related adverse events) of extended treatment with edoxaban up to 12 months in an unselected patient population in routine clinical practice.

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Key information

Conditions

Venous Thromboembolism Cardiovascular Diseases Embolism and Thrombosis Thromboembolism Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

SoonChunHyang University Hospital Gumi, Gyeongsang, Gumi, South Korea

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About this study

Edoxaban is an orally administered anticoagulant that inhibits coagulation factor Xa. It has been approved by the Ministry of Food and Drug Safety (MFDS) in Korea (date: 25th, August 2015) for the: Reduction in the risk of stroke and systemic embolism in patients with non valvular atrial fibrillation (NVAF) Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) Reduction in the risk of recurrent DVT and PE, and by Taiwan Food and Drug Administration (TFDA) in Taiwan (date: 24th, February, 2016) for the Prevention of stroke and systemic embolism in adult patients with NVAF with one or more risk factors, such as congestive heart failure, hypertension, age ≥ 75 years, diabetes mellitus, prior stroke or transient ischemic attack (TIA). Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) following 5 to 10 days of initial therapy with a parenteral anticoagulant.

According to current guidelines, duration of anticoagulant treatment after a venous thromboembolic event varies from 3 months to indefinite treatment depending on the estimated risks of venous thromboembolism (VTE) recurrence and bleeding. Current data for edoxaban are limited to a maximum treatment duration of 12 months.

This non-interventional study aims to gather further insight into efficacy (i.e. symptomatic recurrent VTE) and safety (i.e. bleeding events, liver adverse events, all-cause mortality and other drug related adverse events) of extended treatment with edoxaban up to 12 months in approximately 350 patients in an unselected patient population in routine clinical practice.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Established acute initial or recurrent VTE
  • Patients prescribed treatment with edoxaban according to package information before participation in the trial
  • Written informed consent for participation in the study (ICF)
  • Not simultaneously participating in any interventional study

Exclusion criteria

  • None

Treatment and study plan

Edoxaban

Drug

Prescribed according to approved label

Other names: Lixiana

Primary outcomes

  1. Rate of overall symptomatic VTE recurrence

    Time frame: Baseline to 12 months

    Rate of overall symptomatic VTE recurrence within 12 months

  2. Rate of participants experiencing Real World Safety Data Events

    Time frame: 12 months

    Categories: VTE-related bleeding events, Drug-related adverse events, Cardiovascular Mortality, and All-cause Mortality

Secondary outcomes

  1. Rate of participants taking edoxaban with symptomatic VTE recurrence

    Time frame: 12 months

    Rate of participants taking edoxaban with symptomatic VTE recurrence in 12 months

  2. Rate of participants who permanently discontinued edoxaban with symptomatic VTE recurrence

    Time frame: 12 months

    Rate of participants who permanently discontinued edoxaban with symptomatic VTE recurrence in 12 months

  3. Rate of participants with patient relevant outcomes

    Time frame: 12 months

    Patient relevant outcomes include bleeding events, strokes (ischaemic and haemorrhagic), systemic embolic events (SEE), and hospitalisations related to cardiovascular (CV) condition (including VTE related hospitalisation).

Sponsors and collaborators

Lead sponsor

Daiichi Sankyo

Industry

Registry information

Official study title

Non-Interventional Study on Edoxaban Treatment in Routine Clinical Practice in Patients With Venous Thromboembolism (VTE) in Korea and Taiwan

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Nov 2, 2016
Registry last updated
Dec 23, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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